Study of Cor TRICUSPID ECM Valve Replacement for Treating Tricuspid Valve Disease in Adults and Children

What this Trial Is About

This research aims to evaluate the safety and performance of the Cor TRICUSPID ECM Valve, including the Cor PEDIATRIC Tricuspid ECM Valve, for replacing dysfunctional tricuspid heart valves in both adult and pediatric patients. The study focuses on whether the device can be implanted successfully and safely, and if it effectively manages tricuspid valve disease and dysfunction over a 12-month period. The study also considers that many patients may undergo additional heart valve procedures alongside the tricuspid valve replacement. Participants will receive surgical tricuspid valve replacement with one of the Cor TRICUSPID ECM Valve models, either SIS 1.0 or SIS 2.0, with separate groups for adults and pediatrics. The device is intended to serve as the physiological right-sided atrioventricular valve. The study is non-randomized and includes different arms based on age group and valve model. Follow-up evaluations occur at hospital discharge, 30 days, 6 months, 12 months, and then yearly for up to 5 years after surgery. Participants will undergo preoperative evaluations followed by the valve replacement surgery. Postoperative assessments include monitoring procedural success at 30 days and individual patient success at 6 and 12 months. Additional long-term monitoring will continue annually for up to 5 years to observe safety and effectiveness outcomes. Patient consent, adherence to follow-up schedules, and the ability to return for evaluations are part of the participation requirements.

CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study